This presentation provides an overview of the TGA’s post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.

1. How do listed medicines shape up in the post-market
compliance space?
An update from the Complementary and Over-the-counter
Medicines Branch of the TGA
Dr Allison Jones
Director
Listing Compliance, Complementary and Over-the-counter Medicines Branch
Health Products Regulation Group, TGA
ARCS Scientific Congress
10-11 August 2016

2. Overview
• What is our post-market compliance program?
• 2015-16 Compliance data
• Breaking down the data
• Compliance projects
• Our goals
• What’s in store for the future
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3. What is our post-market compliance program?
• Random reviews
• Targeted reviews
• Investigations (complaints and referrals)
• Project work
• Business improvement
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4. 2015-16 Compliance data
Investigations and outcomes
2014-15 2015-16
Jul–Jun Jul-Jun
Initiated investigations 86 114
Completed investigations
Medicines prioritised for targeted review 24a 69
Referred to another TGA area or government organisation 5a 14
No further action taken 24a 32
Total completed investigations 99 115
a Data collection commenced Jan 2015.
60% of all
investigations
became targeted
reviews
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5. 2015-16 Compliance data
Reviews by type
80% of all reviews had verified
compliance breaches
2014-15 2015-16
Jul-Jun Jul-Jun
Initiated reviews
Targeted reviews 41 173
Random reviews 89 340
Total 130 513
Reviews on hand 188 151
Completed reviews
Targeted reviews 156 158
Random reviews 56 315
Total 212 473
Random up by 560%
Total up by 220%
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6. Outcomes of completed reviews
Compliant,
74, 28%
Cancelled by
TGA after
P2C, 15, 5%
Cancelled by
sponsor
request after
P2C, 29, 11%
Compliant
after P2C,
148, 56%
Random Compliant,
7, 5%
Cancelled by
TGA after
P2C,
29, 20%
Cancelled by
sponsor
request after
P2C,
59, 42%
Compliant
after P2C,
47, 33%
Targeted
How do Listed Medicines shape up in the post-market compliance space?
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7. Breaking down the data
Types of non-compliance identified
Biggest issues account for
~80% of non-compliance
– Labelling
– Advertising
– Evidence
ARTG info
9%
Quality
9%
Labelling/
advertising
40%
Evidence
41%
Safety
0%
Other
1%
Random Reviews
ARTG info
11%
Quality
15%
Labelling/
advertising
36%
Evidence
31%
Safety
6%
Other
1%
Targeted Reviews
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8. Breaking down
the data
Evidence issues in more detail
(based on last half of 2015)
• Highlights
– Biomarkers
 Blood glucose
 Cholesterol
– Arthritis
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9. Compliance projects arising from our data analysis
Blood glucose and cholesterol biomarkers project
• Indications related to the:
– management;
– control;
– maintenance; and/or
– balance
• of normal, healthy or improved blood glucose or cholesterol:
– levels;
– ratios; and/or
– ranges.
‘may help maintain normal blood
glucose levels within the normal
range in healthy individuals’
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10. Compliance projects arising from our data analysis
Blood glucose and cholesterol biomarkers project
• Evidence requirements
– High quality
– Quantifiable data
– Show how levels are maintained / prevented from falling outside the healthy range
– Example: blood glucose
 Reference ranges for normal glucose levels in healthy adults.
Other
glucose fasting: 3-5.4 mmol/L
random: 3-7.7 mmol/L
According to the Australian Medicines Handbook and Royal Australian College of
Pathologists
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11. Our goals
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12. What’s in store for the future
Current priorities
Evidence:
Blood glucose
and cholesterol
Quality:
Aristolochic
acids
Evidence:
Vaginal
probiotics
Improving
education
Upcoming priorities
Evidence:
Macular
degeneration
Regulatory reform:
Medicines & Medical
Devices Review
Quality:
Sunscreens
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